hepatocellular carcinoma. C22.0
Conditions
Interventions
Intervention group: Intravenous injection of the number of 7x10^5 NK cells in 3 periods with an interval of 5 days to 3 patients with Hepathocellular carcinoma.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age of people between 20 and 60 years- Patients receiving the same chemotherapy regimen. Patients who have almost the same tumor size. Diffuse-form in terms of histopathology. Laboratory criteria for the proper functioning of vital organs in the form of:Liver function:Child-pugh A/Bserum aspartate aminotransferase (AST) =100 IU/Lalanine aminotransferase (ALT) =100 IU/Lserum total bilirubin =2 mg/dLRenal function: =1.5 mg/dL serum creatinineCardiac function: Absence of heart enzyme and ECG abnormalities, the survival expectancy is more than 6 months.leukocyte count =3000/mm3neutrophil count =1500/mm3platelet count =100,000/mm3hemoglobin =9.0 g/dLblood urea nitrogen level =25 mg/dL- All patients with active hepatitis B or C were treated with appropriate drugs and treated with targeted drugs.- Women must not be lactating or pregnant, must have a negative serum human chorionic gonadotropin B (HCG) test within 7 days prior to transplant day, and must agree to use an acceptable and reliable method of contraception during the study.- Have not undergone a liver transplant before.- All patients and donors sign an informed consent form.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women- People with hepatitis A, hepatitis E, AIDS or other infectious diseases- Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days- Patients with other serious systemic and psychiatric diseases- Having a history of autoimmune diseases and hypersensitivity- History of receiving any type of cell therapy in the last 6 months- Simultaneous participation in another clinical trial- Diseases such as diabetes mellitus, unstable angina or myocardial infarction within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Checking the safety and toxicity of the injected cells. Timepoint: 28 days. Method of measurement: Any side effects related to cell injection will be checked and recorded during the injection and up to 28 days after the injection.If a complication is seen during or after the infusion, the following actions will be taken based on the CTCAE guideline:In grade 1, only the infusion is stopped.In grades 2 and 3, the infusion is stopped along with anti-allergic treatments, including corticosteroids and antihistamines.In grade 4, in addition to the above, resuscitation measures and care in the ICU department are also recommended. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr javad verdi
Tehran University of Medical Sciences
Outcome results
None listed